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Catalog Number SGC0701 |
Device Problems
Positioning Failure (1158); Unintended Movement (3026)
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Patient Problem
Perforation (2001)
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Event Date 11/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and without the device to analyze, the cause of the reported unintended movement, unable to curve/straighten, and perforation were unable to be determined.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Event Description
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It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 3-4 and enlarged atrium.A mitraclip xtw was selected for treatment and was advanced to the mitral valve and the leaflets were grasped, but the mr did not reduce enough.While under fluoroscopy, and before another grasping attempt was made, the steerable guide catheter appeared torqued and the transseptal access from the sgc was lost.T he device was safely placed in the left atrium.The sgc was no longer in the left atrium, but the cds shaft remained.The sgc was advanced back into the original transseptal puncture site.After this was achieved, steerability in the left atrium could not be performed.It was noted that any sort of device manipulation did not translate into the device.The clip was retracted into the sgc.The steerable guide catheter and mitraclip were removed together from the patient.No clips were implanted.However, after removal of the sgc, an atrial septal defect (asd) was observed.Therefore, an abbott atrial septal defect (asd) closure device was implanted.The patient was discontinued from anesthesia and the procedure was discontinued.The mr remained at grade 3-4.The patient was reported to be stable and transferred to recovery.The patient was discharged on the following day.No additional information provided.
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Search Alerts/Recalls
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